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Trial record 47 of 130 for:    inflammatory breast cancer AND Cancer Center

Sunitinib Malate, Paclitaxel, Doxorubicin Hydrochloride, and Cyclophosphamide Before Surgery in Treating Patients With Stage IIB-IIIC Breast Cancer

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ClinicalTrials.gov Identifier: NCT00513695
Recruitment Status : Active, not recruiting
First Posted : August 9, 2007
Results First Posted : May 10, 2017
Last Update Posted : June 14, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jennifer Specht, University of Washington

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Inflammatory Breast Cancer
Male Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Interventions: Drug: sunitinib malate
Drug: paclitaxel
Drug: doxorubicin hydrochloride
Drug: cyclophosphamide
Biological: filgrastim
Procedure: therapeutic conventional surgery
Other: laboratory biomarker analysis
Other: flow cytometry

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment (Neoadjuvant Chemotherapy Before Surgery)

Patients receive neoadjuvant chemotherapy comprising sunitinib malate PO once daily and paclitaxel IV over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim SC on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.

sunitinib malate: Given PO

paclitaxel: Given IV

doxorubicin hydrochloride: Given IV

cyclophosphamide: Given PO

filgrastim: Given SC

therapeutic conventional surgery: Undergo surgery

laboratory biomarker analysis: Correlative studies

flow cytometry: Correlative studies


Participant Flow:   Overall Study
    Treatment (Neoadjuvant Chemotherapy Before Surgery)
STARTED   68 
COMPLETED   63 
NOT COMPLETED   5 
Discontinued therapy                2 
Progression prior to surgery                3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment (Neoadjuvant Chemotherapy Before Surgery)

Patients receive neoadjuvant chemotherapy comprising sunitinib malate PO once daily and paclitaxel IV over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim SC on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.

sunitinib malate: Given PO

paclitaxel: Given IV

doxorubicin hydrochloride: Given IV

cyclophosphamide: Given PO

filgrastim: Given SC

therapeutic conventional surgery: Undergo surgery

laboratory biomarker analysis: Correlative studies

flow cytometry: Correlative studies


Baseline Measures
   Treatment (Neoadjuvant Chemotherapy Before Surgery) 
Overall Participants Analyzed 
[Units: Participants]
 68 
Age 
[Units: Years]
Median (Full Range)
 50 
 (33 to 79) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      68 100.0% 
Male      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      4   5.9% 
Not Hispanic or Latino      56  82.4% 
Unknown or Not Reported      8  11.8% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      4   5.9% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      2   2.9% 
White      50  73.5% 
More than one race      4   5.9% 
Unknown or Not Reported      8  11.8% 


  Outcome Measures

1.  Primary:   Microscopic Pathologic CR (pCR) Rate   [ Time Frame: At the time of surgery ]

2.  Secondary:   Clinical Complete Response and Correlation With Plasma VEGF, Soluble VCAM (sVCAM), and Circulating Endothelial Cells (CECs) Levels   [ Time Frame: At baseline, after week 12 of therapy, and prior to surgery ]

3.  Secondary:   Relapse Rate   [ Time Frame: Up to two years ]

4.  Secondary:   Time to Disease Progression   [ Time Frame: Up to 2 years ]

5.  Secondary:   Overall Survival   [ Time Frame: Up to 2 years ]

6.  Secondary:   Number and Percent of Subjects Reporting Adverse Events   [ Time Frame: 28 days after the last dose of study drug ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jennifer Specht, MD
Organization: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
phone: (206) 288-6889
e-mail: jspecht@uw.edu



Responsible Party: Jennifer Specht, University of Washington
ClinicalTrials.gov Identifier: NCT00513695     History of Changes
Obsolete Identifiers: NCT00831584
Other Study ID Numbers: 6488
NCI-2010-00607 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: August 8, 2007
First Posted: August 9, 2007
Results First Submitted: March 24, 2017
Results First Posted: May 10, 2017
Last Update Posted: June 14, 2017